Apparatuses, Systems and Methods for Confirming Use of an Oral Appliance

ABSTRACT

An oral appliance constructed with a housing that encloses a recorder and a transceiver. The oral appliance responds to commands received via the transceiver. When so directed, the oral appliance uses one or more sensors alone or in combination to record measurements at periodic intervals. When communicatively coupled to a suitably configured communication device, the oral appliance receives commands that direct the oral appliance to transmit an identifier, the recorded data, or both the identifier and the data. The transmitted data can be used to determine whether the user of the oral appliance has complied with a recommended usage schedule.

BACKGROUND

A number of oral appliances have been developed in association withvarious therapies related to the treatment of sleep apnea, snoring,bruxism, orthodontia, eating disorders and other medical and dentalissues.

Difficulty in breathing while sleeping often manifests itself as snoringor the more serious obstructive sleep apnea. Snoring is a conditionaffecting approximately forty percent (40%) of the adult population,while sleep apnea is believed to affect at least twenty (20) millionpeople.

In turn, bruxism consists of a static and/or dynamic contact between thedentition of the mandible and maxilla. Bruxism is commonly referred toas “tooth grinding,” which results in the physical destruction of toothenamel directly leading to tooth decay as well as more serious problems.Bruxism affects nearly fifteen percent (15%) of the population and inadvanced stages bruxism results in the abnormal and excessive grindingor clenching of teeth while an individual is asleep. Bruxism ismedically classified as parasomnia or sleep disorder.

In turn, temporomandibular joint syndrome (or dysfunction) (“TMJ”) is adisorder effecting the joint between the lower jaw and the skull. Thetemporomandibular joint lies between the temporal bone of the skull andthe mandible of the jaw, and allows the jaw to open and close. The jointis formed by a condyle on the mandible, which hinges and glides in andout of the depression in the temporal bone.

TMJ can be caused by bruxism, malocclusion, trauma, and arthritis. Thereis also an indication that a posterior or backward displacement of thecondyle of the jaw significantly contributes to TMJ pain. TMJ has beenassociated with a wide variety of physical aliments, including migraineheadaches. TMJ related headaches can become so severe as to cause nauseaand blurred vision. Most people afflicted with TMJ suffer from amyofascial pain-dysfunction syndrome primarily as a muscle problemrelated to dental/skeletal relationships and tensional factors. Theeffects can range from mild to severe, including pain in the joint areathat can extend to the shoulders, back, neck, and sinuses.

U.S. Pat. No. 6,769,910 discloses a non-surgical oral appliance forimproving breathing, and abating or completely alleviating snoringsounds, TMJ and bruxism while sleeping. In one embodiment the user isprofessionally fitted for the appliance such that the appliancepositions the mandible in an open, protrusive, predetermined positionsuch that the oral airway permits the enhanced passage of air.

Oral appliances have been developed and prescribed in association withconditions in addition to the above-described oral, respiratory, dentaland developmental disorders. According to the American ObesityAssociation (AOA), obesity is a disease that affects nearly one-third ofthe adult American population. The number of overweight and obeseAmericans has continued to increase since 1960—a trend that is notslowing down. Research conducted by the AOA indicates that 64.5 percentof adult Americans (about 127 million) are currently categorized asbeing overweight or obese. Each year, obesity causes at least 300,000excess deaths in the United States alone, and healthcare costs ofAmerican adults with obesity amount to approximately $100 billion.

Individuals with obesity are at risk of developing one or more seriousmedical conditions, which can cause poor health and premature death. Forinstance, research suggests that obesity is statistically linked toadverse medical conditions, such as diabetes, coronary heart disease,high blood pressure, osteoarthritis, hypertension, and cardiovasculardisease to a name a few of the more severe conditions. The problemsassociated with obesity and other less severe weight issues are notlimited to medical conditions. Obese and overweight people may alsosuffer from a number of other problems (e.g., lifestyle problems,psychological conditions, social problems, etc.).

Currently, there are a number of weight loss methods and devices forenabling people to attempt to manage their weight problems. The mostprevalent methods include dieting, exercising, medications, bodywrapping, surgical procedures, etc. Other weight management solutionsinvolve mechanical devices and dental appliances. One such device ispositioned in the mouth to stimulate salivation and swallowing, such asdisclosed in U.S. Pat. Nos. 3,224,442 and 5,052,410.

U.S. Pat. No. 5,924,422 discloses a removable, retainer-like device thatis molded to fit the contours and configuration of the user's mouth. Theupper surface of the retainer-like device is configured to fit the roofof the user's mouth, while the lower surface is configured to replicatethe roof, or palate, of the user's mouth. The retainer-like device isadapted to be easily and quickly put into use, without any specialtraining, by positioning it in the mouth with the upper surface againstthe palate, and pushing the retainer between the corresponding teeth.When worn, the device effectively lowers the roof of the user's mouth toreduce the overall volume of the oral cavity. The device is intended tobe easily inserted and removed by the user.

Regardless of the malady that a particular oral appliance is attemptingto treat, the oral appliance, if it is to be effective, should be usedin accordance with a prescribed usage schedule to attain the desiredtherapeutic benefits. Accordingly, the dental and medical professions,medical and dental insurers, parents and others interested in a user'scompliance with a prescribed usage schedule for a respective device,recognize the paramount importance of developing systems and methods forensuring a user's compliant use of an oral appliance.

SUMMARY

Embodiments of an oral appliance that records and transfers informationresponsive to a user's usage of the oral appliance comprise a housingconfigured with a power source, a sensor, a recorder, and a transceiver.The recorder is powered by the power source and is configured to recorda measurement responsive to the sensor. The transceiver is coupled tothe recorder and is configured to communicate the measurement responsiveto a command.

An embodiment of a method for confirming compliant use of an oralappliance comprises the steps of providing an oral appliance to a user,the oral appliance configured to record one or more measurementsindicative of placement of the oral appliance in an oral cavity,directing the oral appliance to transfer the measurements and analyzingthe measurement.

Other apparatuses, systems, methods, features and advantages will be orwill become apparent to one with skill in the art upon examination ofthe following figures and detailed description. All such additionalapparatuses, systems, methods, features and advantages are defined andprotected by the accompanying claims.

BRIEF DESCRIPTION OF THE FIGS.

The apparatuses, systems and methods for confirming use of an oraldevice can be better understood with reference to the following figures.The components within the figures are not necessarily to scale; emphasisinstead is placed upon clearly illustrating the principles that supportthe apparatuses, systems and methods. Moreover, in the figures, likereference numbers designate corresponding parts throughout the differentviews.

FIG. 1 is a side view of the head of a user that is using an oralappliance.

FIG. 2 is a perspective view of an embodiment of the oral appliance ofFIG. 1.

FIG. 3 is a cross-sectional view of the oral appliance of FIG. 2 alonglines 3-3.

FIG. 4 is a schematic diagram illustrating an embodiment of the oralappliance of FIG. 3.

FIG. 5 is a schematic diagram illustrating an embodiment of the housingof FIG. 4.

FIG. 6 is a schematic diagram illustrating an embodiment of storagelocations within the memory of FIG. 5.

FIG. 7 is a flow diagram illustrating an embodiment of a method forconfirming use of an oral appliance.

FIG. 8 is a flow diagram illustrating an alternative embodiment of amethod for confirming use of an oral appliance.

DETAILED DESCRIPTION

An oral appliance is constructed with a housing or chamber thatsubstantially encloses a sensor, a recorder, and a transceiver. The oralappliance responds to commands received via the transceiver. The oralappliance is reset or otherwise configured to periodically record ameasurement or measurements for a desired length of time. The oralappliance is prescribed or otherwise provided to a user of the oralappliance. Preferably, before the desired length of time has expired,the user transfers recorded data to a communication device. This can beaccomplished by returning the oral appliance to the provider of thedevice or providing the user with a suitably configured communicationdevice that receives recorded data from the oral appliance and forwardsthe data to the provider to the provider of the device. Whencommunicatively coupled to a suitably configured communication device,the oral appliance receives commands that direct the appliance totransmit the recorded measurements. The transmitted measurements can beused to determine whether the user of the oral appliance has compliedwith a recommended usage schedule.

The sensor is configured such that it is sensitive to one or moreconditions associated with the user's oral cavity. For example, thesensor may be sensitive to a range of temperatures. Generally, the oralappliance will have the same temperature as its surrounding environmentsuch as room temperature when it is not in the oral cavity andapproximately ninety-eight degrees Fahrenheit when the appliance ispositioned within the oral cavity. By periodically recording themeasured temperature of the oral appliance it can be determined with afairly high degree of certainty when the oral appliance was placed inthe oral cavity. By way of further example, the sensor may be sensitiveto other conditions expected in an oral cavity such as hydrogen ionconcentration or pH, moisture or absolute humidity. Absolute humidity,expressed as grams of water vapor per volume of air, is a measure of theactual amount of water vapor or moisture in the air, regardless of theair's temperature.

A temperature sensor can be entirely contained within a housing orcavity formed by a dental acrylic or other material approved for use inan oral cavity. For example, a TS20 temperature sensor is ahigh-precision complementary metal-oxide semiconductor (CMOS)temperature sensor that provides for high-accuracy low-power temperaturemonitoring. With a supply voltage of 2.4V to 6V, the aTS20 is accurateto ±3° C. over a temperature range of −40° C. to 125° C. and has atypical room temperature accuracy of ±0.5° C. Reducing the supplyvoltage to 2.4V does not change the negative and positive temperatureextremes. In addition, the TS20 does not require external calibration.Calibration of each device is performed at the factory. The TS20 isavailable from Andigilog of Tempe, Ariz., U.S.A.

A humidity sensor may have one or more surfaces exposed to the oralcavity with electrical and perhaps additional structural connectorscontained and protected within a housing or cavity formed of dentalacrylic or other material approved for use in an oral cavity. Forexample, a HIH-3602 series sensor provides a 0-100%, non-condensing,sensing solution in a TO-5 can package. The humidity sensor is alow-power device that operates from a supply voltage from 4.0V to 5.8V.The sensor is national institute of standards and technology (NIST)certified and is provided with a NIST sensor-specific printout. TheHIH-3602 humidity sensors are available from Honeywell Sensing andControl of Minneapolis, Minn., U.S.A.

The logarithmic pH scale is a measure of the number of moles of hydrogenions (H⁺) per liter of solution. A pH sensor comprises measurement andreference electrodes. The measurement electrode generates the voltageused to measure a sample solution's pH. The reference electrode includesa barrier configured to screen or separate hydrogen ions from other ionsin the solution. The reference and measurement electrodes generate avoltage directly proportional to the pH of the solution. At a pH of 7(neutral), the electrodes will produce 0 volts between them. At a pHbelow 7 (acid) the electrodes will produce a voltage of one polarity,and at a pH above 7 (caustic) the electrodes will produce a voltage ofthe opposite polarity. The magnitude of the voltage will increase inproportion to the difference in logarithmic concentration from a neutralconcentration of 10⁻⁷ moles of hydrogen ions per liter. The applicationsof microelectronic fabrication techniques such as photolithography andthick- and thin-film metallization can be used to produce highly uniformand reproducible pH sensors that are relatively simple to calibrate andoperate.

The oral appliance can be configured with a combination of sensors thattogether provide data that can be analyzed to confirm compliant use ofthe oral appliance under various conditions. For example, the oralappliance can be configured with sensors responsive to concentrations ofsalt, sugars, fats, proteins, light and motion. Movement of the oralappliance consistent with chewing can be detected by an accelerometer. Aconcentration of salts, fats, proteins and/or sugars can be determinedfrom a silicon-on-insulator based thin-film resistor. Such a sensor isdescribed in “Silicon-On-Insulator Based Thin-Film Resistor for Chemicaland Biological Sensor Applications,” Michael G. Nikolaides, et al.,ChemPhysChem 2003, Vol. 4, pgs. 1104-1106, which is incorporated byreference in its entirety. Light can be detected by a charge-coupleddevice or other photosensors such as those provided in camera phones.Data received from an accelerometer can be correlated with one or moremeasurements of concentrations of salts, fats, proteins and/or sugars inthe oral cavity and/or information from one or more photosensors todetermine that a patient was eating while wearing the device.Furthermore, collected data can be analyzed to determine the quality ofthe patient's diet.

Outputs from the above-described sensors can be analog current, voltage,or frequency; or digital conversions of the same. In some embodimentsthe measurements are recorded in five minute intervals from a start orreset time commanded via an external communication device. Themeasurements can be transferred periodically or in real-time andanalyzed to determine usage patterns and overall compliance with aprescribed therapeutic schedule.

Having generally described the apparatuses, systems and methods forconfirming use of an oral appliance, various additional embodiments willbe described with respect to FIGS. 1-8. By way of example, FIG. 1 is aside view of the head 102 of a user that is using an oral appliance 100.As illustrated in the example embodiment, the oral appliance 100comprises a palatal prosthetic that is shaped to closely contact theuser's palate 104 (within the user's oral cavity). The oral appliance100 is meant to be easily inserted, positioned and removed by a user ofthe oral appliance 100. As will be explained in greater detail below,oral appliance 100 comprises a housing or cavity (not shown) thatisolates and protects the above-described sensor or sensors, as well asa recorder, a power source and a transceiver.

In alternative embodiments, the oral appliance 100 comprises aprosthetic housing that fits within the user's maxilla but does notcontact the user's palate. In these alternative embodiments the housingis suspended in the oral cavity such that a gap is formed between theupper surface of the oral appliance 100 and the user's palate.

The oral appliance 100 includes an upper arch portion, a lower archportion, or both upper and lower arch portions. An upper arch portionmay take the general shape of the user's maxilla or fit within theconfines of the user's maxilla and in some arrangements may surround oneor more of the user's upper teeth. A lower arch portion may take thegeneral shape of the user's mandible or fit within the confines of theuser's mandible above the tongue and in some arrangements may surroundone or more of the user's lower teeth. In alternative embodiments one orboth (when both arch portions are present) of the arch portions maycomprise a housing that contains an internal cavity for substantiallyencompassing the above-described sensors, as well as protecting arecorder, a power source and a transceiver.

As best illustrated in FIG. 1 and briefly mentioned above, oralappliance 100 may be temporarily positioned within the oral cavity ofpatient 102 so that the oral appliance 100 is disposed under thepatient's palate 104 and forms a palatal prosthetic.

Referring to FIGS. 2 & 3, the palatal prosthetic includes a portion 204made from dental acrylic or other materials approved for such oraldevices that extends below palate 104 to encapsulate a sensor orsensors, a recorder, a power source and a transceiver. As illustrated inFIG. 2, the palatal prosthetic is configured with extensions or contactsurfaces. A first contact surface 205 is arranged along the edges of thepalatal prosthetic to limit any forces that the palatal prosthetic wouldapply to the user's maxilla and upper teeth. A second contact surface207 is arranged along the upper surface of the palatal prosthetic. Thesecond contact surface 207 provides a comfortable fit and cushions anyforces that may be applied to the user's palate while chewing food withthe palatal prosthetic in place. In the illustrated embodiment, thesecond contact surface 207 is a quadrilateral with parallel sidesadjacent to the front and rear of the palatal prosthetic. One or both ofthe first contact surface 205 and the second contact surface 207 may bemade from a plasticized methacrylate resin of the acrylic polymerchemical family. A methacrylate is a combination of ethyl acetate,ethanol and methyl ethyl ketone. In alternative embodiments, one or bothof the first contact surface 205 and second contact surface 207 can beconstructed of flexible materials approved for use in an oral cavity.

As illustrated in the cross-sectional view of FIG. 3, the oral appliance100 includes an upper surface 302 to be disposed under the patient'spalate 104 when positioned in the oral cavity. In some embodiments,upper surface 302 (or portions thereof) may rest against the patient'spalate 104. In other embodiments, upper surface 302 does not contact thepatient's palate 104 but is securely and comfortably fixed under palate104. The oral appliance 100 also includes a lower surface 304, whichdefines portion 204 that extends below palate 104 to define a prostheticpalate. Oral appliance 100 also comprises a dental attachment (e.g.,dental wire 202—FIGS. 2 & 3), which may be used to securely fix the oralappliance 100 when it is positioned as desired within the oral cavity ofuser 102 as described above. It should be appreciated that the position,spatial orientation, etc. of dental wire 202 may be varied from thatshown in FIGS. 2 & 3. Furthermore, additional dental attachments may beattached (e.g., integrally or otherwise) to dental wire 202. Inalternative embodiments, dental wire 202 may be replaced with a moresuitable dental attachment(s) based on a particular orthodonticconfiguration. Nonetheless, in the embodiment illustrated in FIGS. 2 &3, dental wire 202 extends from the lateral sides of dental appliance100.

FIG. 4 is a schematic diagram illustrating an embodiment of the oralappliance 100 of FIG. 3. As illustrated in the rear view of FIG. 4, theoral appliance 100 includes a housing 400 (shown with hidden lines) thatforms an internal cavity 410 within the dental acrylic. As will beexplained in greater detail below, housing 400 protects elementsconfigured to periodically sense and record one or more environmentalconditions surrounding the oral appliance 100 to identify to a reviewerof the recorded information the usage habits of the user 102 of oraldevice 100. In the embodiment illustrated in FIG. 4, housing 400comprises a lower surface 402, an opposing upper surface 404, aright-side surface 406 and an opposing left-side surface 408. It shouldbe understood that alternative arrangements are possible including thosewhere the dental acrylic conformally coats portions of one or moresensors and entirely coats the power source, recorder and transceiver.

FIG. 5 is a schematic diagram illustrating the arrangement of a powersource 520, a sensor 530 and a recorder 550 and transceiver 540 on anintegrated circuit 510 within housing 400. In the illustratedembodiment, housing 400 entirely encompasses integrated circuit 510,power source 520, sensor 530, and antenna 560. In alternativeembodiments (not shown), sensor 530 or other sensors such as sensor 580may extend to or through a surface of housing 400 such that a portion ofthe sensor is exposed to the user's oral cavity.

As illustrated in FIG. 5, power source 520 is coupled and provides powerto integrated circuit 510. Specifically, a positive terminal of powersource 520 is electrically connected to a power input pin via conductor512 and a negative terminal of power source 520 is electricallyconnected to a ground input pin via conductor 514.

Integrated circuit 510 includes recorder 550 and transceiver 540. Sensor530 is coupled to recorder 550 via link 518. Sensor 580 is coupled torecorder 550 via link 524 and link 526. Sensor 580 encloses saliva andother liquids 581, which translate through membrane 585 from the user'soral cavity. Link 524 is coupled to measurement electrode 582. Link 526is coupled to reference electrode 584. Transceiver 540 is coupled torecorder 550 via link 557. Transceiver 540 is coupled to antenna 560 vialink 516. Transceiver 540 is also coupled to connector 570 via link 522.In the illustrated embodiment, connector 570 is protected from theuser's oral cavity via cover 575. Cover 575 is arranged so that it canbe removed when a technician desires to communicatively coupletransceiver 540 via a wired connection to external communication devicesand replaced when oral appliance 100 is returned to the user. Sensor 530is responsive to temperature, motion or both. Sensor 580 is responsiveto humidity, pH, and concentrations of salts, fats, proteins andcarbohydrates including glucose, sucrose, and fructose present inbeverages and food in the patient's oral cavity. It should be understoodthat alternative arrangements of sensor 580 (not shown) may be devisedto place sensor 580 such that it can detect the presence of food andbeverages in the patient's oral cavity. In these alternativearrangements, controller 552 can be configured to record measurementsfrom sensor 580 when movement of the oral appliance consistent withchewing is detected.

Recorder 550 includes controller 552, memory 554 and timer 555.Controller 552 is coupled to memory 554 via bus 553. Controller 552 isfurther coupled to timer 556 via link 555.

Transceiver 540 includes encoder/decoder 542 and modulator/demodulator544. Encoder/decoder 542 is coupled to modulator/demodulator 544 via bus543.

In operation, a radio-frequency signal containing one or more commandsfrom a suitably configured communication device is received via antenna560 and a tuner (not shown). The received signal is forwarded tomodulator/demodulator 544 via link 516. When the oral appliance 100 iscoupled via a wired connection to a communication device (not shown),commands can be forwarded to modulator/demodulator 544 via connector 570and link 522. Modulator/demodulator 544 detects and separatesinformation from the received signal. The information is forwarded toencoder/decoder 542 via bus 543. Encoder/decoder 542 converts thereceived information to a format compatible with controller 552.Controller 552 responds in accordance with the one or more receivedcommands. For example, an identifier set command includes a uniqueidentifier that can be stored in memory 554, a start time reset commandincludes information responsive to a time or a time and date, aninterval set command includes information that defines a time intervalbetween measurements, a transmit command instructs controller 552 toread and communicate each of the recorded measurements, a clear commanddirects controller 552 to remove recorded measurements from memory 554.A suitably configured communication device may send multiple commandswhen oral appliance 100 is within range (in a wireless data transfermode) or directly coupled via connector 570 and link 522 (in a wireddata transfer mode). It should be understood that antenna 560 andconnector 570 as well as link 516 and link 522 could be replaced by aninfrared transmitter (e.g., a diode) and infrared sensitive device tocommunicate with an external communication device wirelessly.

During a session, which is defined as the time between a start timereset command and a transmit command, controller 552 in accordance withperiodic signals received via link 555 from timer 556 latches a currentor a voltage provided by sensor 530.

In some embodiments, controller 552 is configured with an analog todigital converter, which generates a digital representation of theanalog output from sensor 530. In these embodiments controller 552simply forwards the latched and digitized measurement into the nextavailable location within memory 554. In other embodiments, memory 554is configured with calibration information, which is used to convert therecorded measurement to a scale. When the sensor 530 in these otherembodiments is responsive to temperature, the scale may be degreesFahrenheit or degrees Celsius. When the sensor 530 in these otherembodiments is responsive to humidity, the scale may be a percentagefrom 0% (an environment devoid of water vapor) to 100% (an environmentcompletely saturated with water vapor). Sensor 580 as described abovemay produce relative voltages, the polarity and magnitude of which areindicative of the pH of the fluid 581. Regardless of the nature ofsensor 530 and/or sensor 580, converted measurements are stored in thenext available location within memory 554.

Memory 554 includes adequate storage locations to store measurements foran extended session. When the user 102 of oral appliance 100 fails toplace the oral appliance 100 within signal range of a suitablyconfigured communication device and controller 552 has forwarded ameasurement to each available memory location within memory 554,subsequent measurements will be forwarded to and will overwritemeasurement information in the same sequence as previous measurementswere stored in memory 554. It should be understood that when oralappliance 100 is within range of a communication device measurements canbe sent in near real-time from the oral appliance 100 to thecommunication device.

FIG. 6 is a schematic diagram illustrating an embodiment of storagelocations within the memory 554 of FIG. 5. As shown in FIG. 6, memory554 includes identifier store 610, start time store 620, interval store630, and measurement store 640. As previously described, identifierstore 610 is a designated memory location for a unique identifier fororal appliance 100. Start time store 620 is a designated memory locationfor a start time. Interval store 640 is a designated memory location foran interval or duration of time that controller 552 will wait betweenrecording and storing an environmental parameter as determined by sensor530. As further indicated in FIG. 6, measurement store 640 includes manydesignated memory locations, such as location 641, location 642,location 643 through to location 644 in a leftmost column of locations,through to location 645, the last location in a rightmost column ofmeasurement store 640. It should be understood that each of theindividual measurement locations could be arranged in other sequencesseparate and distinct from the sequence shown in FIG. 6.

FIG. 7 is a flow diagram illustrating an embodiment of a method 700 forconfirming use of an oral appliance 100. In this regard, the functionsassociated with blocks 720 and 730 represent respective specified stepsor functions that can be embodied in software and/or a combination ofhardware and firmware. When embodied in software and/orhardware/firmware, blocks 720 and 730 represent modules, segments, orportions of code, which comprise one or more executable instructions forimplementing the specified function(s). Method 700 begins with block 710where an oral appliance 100 is provided to a user 102. As describedabove, the provided oral appliance 100 is configured to record ameasurement or measurements indicative of placement in the oral cavityof user 102. In preferred embodiments, oral appliance 100 is directed toperiodically record one or more specified measurements over a selectlength of time that does not exceed the capacity of a memory device tosave the measurements. Thereafter, as indicated in block 720, the oralappliance 100 is directed to transfer the measurement or measurements.As shown in block 730, the received information is analyzed to see if itconfirms the user's usage (i.e., placement) of the oral appliance 100 inthe oral cavity.

FIG. 8 is a flow diagram illustrating an alternative embodiment of amethod 800 for confirming use of an oral appliance 100. In this regard,each block represents a specified step or function. When embodied insoftware and/or hardware/firmware, each block represents a module,segment, or portion of code, which comprises one or more executableinstructions for implementing the specified function(s).

Operational software programs that may be used by a communicationdevice, as well as operational software programs that may be used inconjunction with a computer communicatively coupled to the communicationdevice, which comprise an ordered listing of executable instructions forimplementing logical functions, can be embodied in any computer-readablemedium for use by or in connection with an instruction execution system,apparatus, or device, such as a computer-based system,processor-containing system, or other system that can fetch theinstructions from the instruction execution system, apparatus, or deviceand execute the instructions. Consequently, portions of method 800 canbe embodied on a computer-readable medium.

Alternative method 800 begins with block 810 where a communicationdevice is used to communicate with and configure oral appliance 100. Inblock 820, the configured oral appliance 100 is provided to a user. Theuser may be instructed at this or some other time to begin a scheduledor prescribed therapy by positioning oral appliance 100 in the user'soral cavity for a desired amount of time. In some embodiments, thisprescribed or desired use may comprise a length of time for use of thedevice within each 24-hour period from receipt of the device until afuture appointment. When the oral appliance 100 is configured to limitthe volume of the oral cavity, as a weight loss aid, the oral appliance100 may only need to be present during meal times to be effective.However, a physician or other party interested in the user's compliantuse of oral appliance 100 may require the user to show use through asignificant portion of each day. When this is the case, the oralappliance 100 may be configured to measure and record one or moreenvironmental parameters in intervals shorter than 5 minutes.

When the user 102 is in possession and is presumably using the oralappliance 100 in accordance with the prescribed or desired schedule, theoral appliance 100 is measuring and recording at least one environmentalparameter every few minutes. The query of block 830 and wait block 835are repeated until as indicated in query block 830, oral appliance 100is communicatively coupled to a suitably configured communicationdevice. When this is the case, as indicated by the flow control arrowlabeled, “YES,” exiting block 830, method 800 continues with optionalblock 840, where the communication device communicates a command to theoral appliance 100 to transfer an identifier. The identifier associatedwith the oral appliance 100 may be an alphanumeric string unique to theparticular oral appliance 100 presently in close proximity to thecommunication device. In alternative embodiments, the identifier may bea number or consist entirely of letters.

In block 850, the communication device directs the oral appliance 100 totransfer one or more measurements indicative of the user's use of theoral appliance 100 since it was first presented to the user and/or sincethe one or more measurements were transferred from the oral appliance100. In block 860, a query is performed to determine if the datatransfer is complete. When the data transfer has not been completed, asindicated by the flow control arrow labeled, “NO,” exiting block 860, await function or step is performed as indicated in block 865.Thereafter, processing continues with the query of block 860 until it isthe case that the data transfer is complete. Once the data transfer iscomplete as indicated by the flow control arrow labeled, “YES,” exitingblock 860, the communication device directs the oral appliance 100 toerase the stored measurements (in block 870). In block 880, thecommunication device or a computing device communicatively coupled tothe communication device analyzes the one or more measurements todetermine if the user's use of the oral appliance 100 is in accordancewith one or more prescribed therapy schedules.

While various embodiments of the apparatuses, systems and methods forconfirming use of an oral appliance have been described, it will beapparent to those of ordinary skill in the art that many moreembodiments and implementations are possible that are within the scopeof the accompanying claims. Accordingly, the apparatuses, systems andmethods for confirming use of an oral appliance are not to be restrictedbeyond the attached claims and their equivalents.

1. An oral appliance, comprising: a housing configured for placement within an oral cavity, the housing comprising: a power source; a sensor; a recorder powered by the power source, coupled to the sensor and configured to record a measurement responsive to the sensor; and a transceiver coupled to the recorder and configured to communicate the measurement responsive to a command.
 2. The oral appliance of claim 1, wherein the sensor is sensitive to temperature.
 3. The oral appliance of claim 1, wherein the sensor is sensitive to humidity.
 4. The oral appliance of claim 1, wherein the sensor is sensitive to motion.
 5. The oral appliance of claim 1, wherein the sensor is sensitive to a concentration of sodium chloride.
 6. The oral appliance of claim 1, wherein the sensor is sensitive to a concentration of a carbohydrate selected from the group consisting of glucose, fructose and sucrose.
 7. The oral appliance of claim 1, wherein the sensor is sensitive to light.
 8. The oral appliance of claim 1, wherein the recorder and the transceiver are implemented on an integrated circuit.
 9. The oral appliance of claim 8, further comprising: a timer.
 10. The oral appliance of claim 9, wherein the transceiver receives a timer command from a communication device.
 11. The oral appliance of claim 1, further comprising: a controller.
 12. The oral appliance of claim 11, wherein the controller directs the transceiver to transmit an identifier responsive to a command received by the transceiver.
 13. The oral appliance of claim 12, wherein the command directs the controller to perform one of a start, pause or terminate operation.
 14. The oral appliance of claim 1, further comprising: a memory for storing the measurement at periodic intervals.
 15. The oral appliance of claim 14, wherein the memory stores a start time.
 16. The oral appliance of claim 14, wherein the memory is erased responsive to an erase command received by the transceiver.
 17. A method for confirming compliant use of an oral appliance, the method comprising: providing an oral appliance to a user, the oral appliance configured to record a measurement indicative of placement of the oral appliance in an oral cavity; directing the oral appliance to transfer the measurement; and analyzing the measurement.
 18. The method of claim 17, wherein the measurement comprises a temperature reading.
 19. The method of claim 17, wherein the measurement comprises a humidity reading.
 20. The method of claim 17, wherein directing the oral appliance to transfer the measurement comprises confirming the successful transfer of the measurement to the communication device and directing the oral appliance to erase the measurement.
 21. The method of claim 17, wherein directing the oral appliance to transfer the measurement comprises communicatively coupling the oral appliance to a communication device.
 22. The method of claim 21, further comprising: transmitting a command to the oral appliance.
 23. The method of claim 21, further comprising: providing the communication device to a medical professional.
 24. The method of claim 17, wherein directing the oral appliance to transfer the measurement comprises confirming the successful transfer of the measurement to the communication device and directing the oral appliance to erase the measurement.
 25. The method of claim 17, wherein analyzing the measurement comprises communicating information to a computing device.
 26. The method of claim 17, further comprising: directing the oral appliance to transfer an identifier.
 27. The method of claim 17, wherein the measurement is responsive to the concentration of hydrogen ions.
 28. The method of claim 17, wherein the measurement is responsive to a concentration of sodium chloride.
 29. The method of claim 17, wherein the measurement is responsive to a concentration of a carbohydrate selected from the group consisting of glucose, fructose and sucrose.
 30. The method of claim 17, wherein the measurement is responsive to light.
 31. An oral system for determining compliant use over time by a patient, comprising: an orthodontic appliance; a sensor integrated with the orthodontic appliance and able to detect a condition in the patient's oral cavity; and a transceiver integrated within the orthodontic appliance and responsive to a command originating from a communication device.
 32. The oral system of claim 31, wherein the orthodontic appliance comprises a retainer.
 33. The oral system of claim 31, wherein the sensor is sensitive to temperature.
 34. The oral system of claim 31, wherein the sensor is sensitive to humidity.
 35. The oral system of claim 31, wherein the sensor is sensitive to pressure.
 36. The oral system of claim 31, wherein the sensor is sensitive to a concentration of hydrogen ions.
 37. The oral system of claim 31, further comprising: a recorder coupled to the sensor and the transceiver, the recorder configured to periodically store at least one measurement received from the sensor.
 38. The oral system of claim 37, wherein the recorder transfers stored measurements from two or more sensors with different sensitivities, the stored measurements recorded proximal in time to one another. 